Free Download USP GC <800>Register for live webcastGC <800> Infographic. NIOSH response: NIOSH relies on a range of knowledge, experience, and skills to evaluate drugs for placement on the List, including but not limited to pharmacology, toxicology, medicine, and risk evaluation. Please explain. Thank you for taking the time to confirm your preferences. See https://www.cdc.gov/niosh/docs/2016-161/default.html for all drugs with special handling information added to the 2016 List. These changes now reflected in the draft Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (draft Procedures) include the clarification of some language and streamlining the procedures NIOSH uses to determine the hazard potential of a specific drug. Although assessing specific controls for specific exposure situations is beyond the scope of the List, information about the use of respiratory protection in the handling of hazardous drugs is found in the draft risk management document, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which is available in the docket for this activity. Which unique ingredient identifier is the most useful for users of the List? NIOSH response: As presented in the 2018 FRN, NIOSH reviewed cetuximab, ibrutinib, ipilimumab, necitumumab, nintedanib, nivolumab, palbociclib, panitumumab, ramucirumab, and ruxolitinib for placement on the List and, for each, the available information showed a toxic effect that does not meet the NIOSH definition of a hazardous drug. Am J Heath-Syst Pharm 65:861-865; Krstev S, Perunicic B, Vidakovic A [2003]. The rationale for placing interferon beta-1b on the List is that information from the package insert indicated reproductive toxicity: spontaneous abortion in human clinical trials. Relevant information about this document from Regulations.gov provides additional context. ET on July 30, 2020 is not clearly outlined with respect to the evaluation process. Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings is intended to formalize the methodology that NIOSH uses to add hazardous drugs to its list. NIOSH response: NIOSH has evaluated each drug individually and not by class of drug. As such, they should be moved from Table 1 to another place on the List. In order to clarify that the List is a hazard identification tool, NIOSH has removed this table from the document. The NIOSH definition of a "hazardous" drug is a drug that is: Approved for use in humans11 by the FDA's Center for Drug Evaluation and Research (CDER);12 Not otherwise regulated by the U.S. Nuclear Regulatory Commission;13 and Either: hospital. publication in the future. In very few cases, if any, would sufficient studies be available to conduct a formal meta-analysis relating to a specific drug. NIOSH response: Drugs still under investigation are not included on the List because no scientific information, including information normally provided in package inserts, is available for NIOSH review. This prototype edition of the Seven commenters expressed concern about the impact of USP <800> on the NIOSH List, and, in turn, the effect on small pharmacies that compound pharmaceutical drugs. 04/30/2020 at 8:45 am. In the 2016 List, Table 5 provided information on recommended exposure controls for hazardous drugs based on formulations. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a notice published in the Federal Register. and includes the following questions. Director,National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Only when a labeling change results in the addition of MSHI to a package insert will NIOSH automatically consider the drug to be a hazardous drug and add it to the List. . USP <800> Public comment: Several commenters offered suggestions on the document's use of USP <800>. The drugs and rationales for each of them include the following: NIOSH response: Each of these drugs has either been previously reviewed and found not to meet the NIOSH definition of a hazardous drug, falls outside the scope of the List, or is slated for review in the future. b. Peer review comment: NIOSH should mention some other common healthcare job categories that are likely to be exposed . regulatory information on FederalRegister.gov with the objective of You will be subject to the destination website's privacy policy when you follow the link. A new peer review was not conducted. [FR Doc. Hormonal agents that are classified by NTP as known to be a human carcinogen or by IARC as carcinogenic or probably carcinogenic will be identified in Table 1. were derived. NIOSH response: The manufacturer provided information indicating that multiple evaluations of pregnancy registries did not provide any signals suggesting negative pregnancy outcomes associated with interferon beta-1b. As discussed extensively in the notice published February 14, 2018, NIOSH identified 275 potentially hazardous drugs between January 2014 and December 2015 (83 FR 6563). Peer review comment: NIOSH's discussion of an employer-performed site-based risk assessment to control the risk of exposure is confusing when placed in a document describing NIOSH's hazard identification procedures. Federal Register issue. According to the safety data sheets for botulinum toxins, no engineering controls or respiratory protective devices are required for safe handling. Is the information threshold scientifically sound? Information about this document as published in the Federal Register. NIOSH response: The majority of drug evaluations are based on information provided in the drug package insert; NIOSH relies on the quality of science Start Printed Page 25442generated by a drug manufacturer, subsequently reviewed by FDA during the drug approval process, and then published in the drug package insert. While NIOSH defines criteria and identifies hazardous drugs, USP developed standards for handling these hazardous drugs to minimize the risk to public health. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. NIOSH Peer Review Agenda, https://www.cdc.gov/niosh/review/peer/isi/healthsafetyrisks.html. informational resource until the Administrative Committee of the Federal This is because there is insufficient information to establish an exposure limit and, therefore, one should err on the side of caution and apply the ALARA principle. Although there is currently some guidance in the footnotes, it may be worthwhile to consider a more detailed evaluation process of relevant studies and place it in a more prominent location in the document or possibly as an Appendix.. Each document posted on the site includes a link to the In its place, NIOSH has developed a new, comprehensive document on risk management strategies entitled, Managing Hazardous Drug Exposures: Information for Healthcare Settings, which includes a revision of this table on control approaches to safe handling of hazardous drugs. Register documents. These cookies may also be used for advertising purposes by these third parties. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. The last paragraph of this section is particularly confusing to the reader. Therefore, NIOSH no longer proposes to place osimertinib on the List. [3] USP <800> requires an assessment of risk, which is a consideration of the type of HD, dosage form, risk of exposure, packaging, and manipulation. From my perspective, as a minimum, this should include porters, ward aides and unit clerks.. Carcinogenicity: Cited studies demonstrated an increased incidence of various oncologic presentations (hepatocellular adenoma/carcinoma, interstitial cell hyperplasia, and uterine endometrial adenocarcinoma), in multiple animal species (rat and mice) at exposure lower than human doses (0.7-1.4 fold in rats and 0.3-0.7 fold in mice compared to a human dosing). NIOSH response: NIOSH applies the same methodology for evaluating each drug approved by the FDA Center for Drug Evaluation and Research, regardless of class. Peer review comment: Following the 60-day period to allow for public and stakeholder consultations, it is unclear if NIOSH will be responding to any parties that have provided comments. NIOSH also invites comments specifically on the following questions related to this activity: 1. Often the mechanism of action for the drug being assessed is known and can be compared to other drugs of a similar structure/activity. See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. Because the way cancer is treated therapeutically has changed, and the classes of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic or genotoxic. The large molecular size limits dermal absorption and aerosolization. headings within the legal text of Federal Register documents. Please provide any additional studies or scientific information that evaluate or validate engineering, work practice or administrative controls to reduce exposures to hazardous drugs in healthcare settings. If a meta-analysis or systematic review is warranted for a reevaluation, NIOSH would consider these criteria on a case-by-case basis. Comment: Monoclonal antibodies do not have a cytotoxic mechanism of action and, as such, do not pose the same level of occupational risk or toxicity as conventional antineoplastic drugs. NIOSH response: It is NIOSH practice to respond to all stakeholder and public comments and peer reviews in a Federal Register notice or in a document posted in the relevant NIOSH docket, to maintain a transparent and thorough administrative record. The draft Procedures document is now focused on NIOSH's procedure for identifying hazardous drugs and no longer discusses managing the risk of exposure. If new information becomes available about any of these drugs, NIOSH will reevaluate them in a future update to the List. NIOSH is seeking input from the public on the draft risk management strategies document and table to ensure that they contain accurate and helpful information. Is there a scientific justification for them? Peer review comment: It may be inappropriate for NIOSH not to place drugs on the List when NIOSH has determined there is insufficient information to support the placement. 6. NIOSH response: The daily therapeutic dose at which serious organ toxicity, developmental toxicity, or reproductive toxicity occurs (10 mg/day in human adults and 1 mg/kg per day in laboratory animals) has long been used by the pharmaceutical industry to develop occupational exposure limits (OELs) of less than 10 g/m[3] after applying appropriate uncertainty factors. documents in the last year, 29 Register (ACFR) issues a regulation granting it official legal status. Because this issue is a matter of delivery form, rather than inherent toxicity, it is currently beyond the scope of the List. There are no human studies relating to the developmental effects of daratumumab or dinutuximab. by the Securities and Exchange Commission Accordingly, NIOSH proposes to place exenatide on the List. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard-setting progress. Document Drafting Handbook NIOSH's definition of a hazardous drug only covers drugs approved by FDA's Center for Drug Evaluation and Research and is not considered for inclusion on the, Dihydroergotamine AHFS Class: 5-hydroxytryptamine (HT) receptor binder, Ivabradine AHFS Class: Hyperpolarization-activated cyclic nucleotide-gated (HCN) blocker. NIOSH will consider identifying hazardous drugs that are known to be volatile in future updates to the List. Are the screening and evaluation categorization processes described by the draft policy and procedures scientifically sound? offers a preview of documents scheduled to appear in the next day's . corresponding official PDF file on govinfo.gov. Please refer to the current edition of the USP-NF for official text. establishing the XML-based Federal Register as an ACFR-sanctioned Comment: Ivabradine should not be placed on the List. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. However, the lack of Furthermore, animal studies must be evaluated for the recovery/reversibility of effects and the pharmacological relevance of the species studied. Thus, neither was proposed for placement on the List in the February 2018 FRN. Federal Register provide legal notice to the public and judicial notice NIOSH is adding text to clarify the agency's intent. These tools are designed to help you understand the official document documents in the last year, 1407 This clearly infers human studies only. If emailing please type 508 Accommodation PR#9342 without quotes in the subject line of the email. 1. The draft Procedures reflects peer review and public comment; the list of drugs proposed for placement on the List has been updated based on the revised draft Procedures. Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. Significant peer review and public comments on the draft Policy and Procedures are summarized and answered below in Section II; public comments on specific drugs are summarized and answered below in Section III. The safety data sheet for this drug indicates that it does not pose a heightened risk to healthcare workers. NIOSH also conducted a peer review, with four independent reviewers, of the draft Policy and Procedures.[2]. However, the remaining parts of the draft policy and procedures mentions that animal studies should be reviewed . NIOSH response: In 2004, NIOSH used lists from several organizations as examples of hazardous drugs. NIOSH determined that grouping all antineoplastic drugs together in one table is no longer the most useful or informative for the user. NIOSH has determined that exenatide extended-release caused a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats. The United States Pharmacopeia General Chapter <800> standards focus on controlling occupational exposure to hazardous drugs while also protecting patients. November 02, 2020 USP 800 For Pharmacists & Healthcare Workers An Overview of USP 800 The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings. Embryo-fetal toxicity is shown to happen at dose exposure 1.5 times the recommended ingested human dose of 80 mg; it is unlikely that a healthcare worker would accidentally be exposed to osimertinib during handling at levels found to cause embryo-fetal harm. Comment. 2. provide legal notice to the public or judicial notice to the courts. USP <800> incorporates by reference the NIOSH List and imposes certain requirements on its users when handling certain drugs on the List. developer tools pages. Six commenters were critical of the methodology NIOSH described for adding drugs to the List and asked that NIOSH clarify the language in certain sections of the draft Policy and Procedures. We take your privacy seriously. Not allowing public commenters to review peer reviews before submitting their own comments to the docket is in conflict with the principle of transparency established in the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664, Jan. 14, 2005). Accordingly, the List is derived only from drugs approved by FDA's Center for Drug Evaluation and Research. on . whereas public comment, including stakeholder review, often provides NIOSH with crucial feedback on how a project or publication may impact the interests of employees, stakeholder organizations, or other parties. documents in the last year, 153 'When available, published, peer-reviewed scientific literature about the hazard potential of a particular drug, including any studies cited in the package insert that are relevant to workers in a health care setting.' Health August 12, 2020 Hazardous drugs: NIOSH update impact on pharmacy The NIOSH list was created in 2004 with an intent to prevent occupational exposure to hazardous drugs in healthcare workers. Urofollitropin AHFS Class: Ovulation stimulator. and services, go to In this Issue, Documents NIOSH response: NIOSH has determined that dihydroergotamine has demonstrated reproductive toxicity in experimental animals. Are these standard or commonly accepted definitions of 'low dose' exposure? Seven commenters opposed the inclusion of biological drug products (monoclonal antibodies) on the List. edition of the Federal Register. Answer: The NIOSH list is not intended to rank hazards. This text is a courtesy copy of General Chapter <800> Hazardous Drugs - Handling in Healthcare Settings, intended to be used as an informational tool and resource only. NIOSH response: While some drugs may have low bioavailability by relevant routes of exposure due to molecular weight, other factors in the characterization of the hazard are considered as well. Workers can be protected from exposures to hazardous drugs through engineering and administrative controls, and proper protective equipment. Therefore, in accordance with the draft Procedures some monoclonal antibodies may not meet the NIOSH definition of the term hazardous drug. Because the list of drugs proposed for placement on the List has been updated based on the draft Procedures, the monoclonal antibodies bevacizumab and trastuzumab are no longer proposed for placement on the List. USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. documents in the last year, 931 ET on July 30, 2020. The new drafts, entitled the Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) and the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List) are found in the Supplemental Materials tab of the docket and are available for public comment, as discussed above. and III.B: bevacizumab, botulinum toxins, darbepoetin alfa, interferon beta-1b, osimertinib, trastuzumab, and triazolam. NIOSH response: Drugs still under investigation are not included on the List because no scientific information, including information normally provided in package inserts, is available for NIOSH review. Therefore, at this time NIOSH is no longer proposing to place the class of botulinum toxins on the 2020 List. Does the draft policy and procedures clearly describe the process used by NIOSH to screen and evaluate drugs? on FederalRegister.gov After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. NIOSH may conduct a meta-analysis or systematic review when reevaluating the placement of a drug already on the List, if the available evidence warrants such a review. This information is not part of the official Federal Register document. electronic version on GPOs govinfo.gov. Employing this same train of thought to the draft policy and procedures, it would, in my opinion, be a best practice to add the drug that has insufficient information to the List until suitable scientific evidence demonstrates that it should not be included.. relative risk, odds ratios, etc. 05/01/2023, 39 General Chapter <800> was published on February 1, 2016. The only potential risk to healthcare workers is of an accidental needle stick, which would not inject a pharmacologically active dose. Accordingly, the monoclonal antibodies bevacizumab, blintumomab, and trastuzumab should not be placed on the List, and pertuzumab should be removed from Table 1. Peer review comment: The frequency of review of the FDA database should be specified earlier in the draft. In the case of a drug being reevaluated, conclusions about study quality would be discussed in a Federal Register notice. The 13 drugs proposed for placement on the List are presented for public comment in the table below, along with the rationale for their placement on the List. to the courts under 44 U.S.C. NIOSH response: NIOSH has determined that teratogenicity or other developmental toxicity after exposure to osimertinib were observed at doses higher than the maximum recommended human dose and reproductive effects at doses lower than the maximum recommended human doses were equivocal. Moreover, caution should be taken when making determinations about potentially hazardous drugs because causality is not necessarily demonstrated by a strong association just as absence of causality is not necessarily demonstrated by weak associations; associations that demonstrate a monotonic trend in health outcome frequency (steadily increasing or decreasing without ever changing direction) are not necessarily causal if a confounding factor demonstrates a dose-response relationship with the health outcome; and prior beliefs should not be allowed to cloud judgment with regard to plausibility.
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